Sunday, November 6, 2016

CDC Whistleblower raises concern on Zika test sensitivity

While the globe has been put on edge because of the the Zika
virus the Center for Disease Control and Prevention has dealt with their own
internal strife regarding Zika. The debate was hinged on the best way to test
for Zika cases. With such a back log of Zika samples the CDC has received pressure
to find quicker ways to test and process these samples. Thus in March the CDC submitted
an application for FDA approved emergency use of a new test Trioplex which can
test for Zika as well as dengue and chikungunya. A day later the test was
approved and being shipped to public health labs around the US. But Robert
Lanciotti, chief of one of CDC’s viral diagnostic labs, found that the test
missed 39 percent of of Zika infections as compared to the previous Singleplex
diagnostic test, which contradicted the lab in Puerto Rico which found that the
test was not less sensitive than the SIngleplex test. Regardless the Trioplex
was still recommended thus Lanciotti emailed 30 public health laboratories stating
that he will continue to use the Singlplex test and that the Trioplex test is
less sensitive. This caused much confusion amongst laboratories and CDC
officials continued with their original recommendation and demoted Lanciotti. Lanciotti
filed a whistleblower retaliation claim and was eventually reinstated to his
original position and in August the CDC increased its blood volume recommendations
for the diagnostic test so that more viral sample will be present and can improve
the sensitivity of sample testing.